Pharmacy Prior Authorization Criteria

Vyvgart (efgartigimod alfa-fcab)

Indications for Prior Authorization

Vyvgart (efgartigimod alfa)

• For diagnosis of Generalized Myasthenia Gravis (gMG)
  Indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.

Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc)

• For diagnosis of Generalized Myasthenia Gravis (gMG)
  Indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.

• For diagnosis of Chronic inflammatory demyelinating polyneuropathy (CIDP)
  Indicated for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP)

Criteria

Vyvgart, Vyvgart Hytrulo

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Generalized myasthenia gravis (gMG)

• Diagnosis of generalized myasthenia gravis (gMG)
AND
• Patient is anti-acetylcholine receptor (AChR) antibody positive
AND
• One of the following:
• Trial and failure, contraindication, or intolerance to two immunosuppressive therapies (e.g., glucocorticoids, azathioprine, cyclosporine, mycophenolate mofetil, methotrexate, tacrolimus)
OR
• Both of the following:
• Trial and failure, contraindication, or intolerance to one immunosuppressive therapy (e.g., glucocorticoids, azathioprine, cyclosporine, mycophenolate mofetil, methotrexate, tacrolimus)
AND
• Trial and failure, contraindication, or intolerance to one of the following:
• Chronic plasmapheresis or plasma exchange (PE)
• Intravenous immunoglobulin (IVIG)
AND
• Prescribed by or in consultation with a neurologist

Vyvgart, Vyvgart Hytrulo

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Generalized myasthenia gravis (gMG)

• Patient demonstrates positive clinical response to therapy

Vyvgart Hytrulo

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)
For diagnosis of Chronic inflammatory demyelinating polyneuropathy (CIDP)

• Diagnosis of chronic inflammatory demyelinating polyneuropathy (CIDP) as confirmed by all of the following [3]:
• Progressive symptoms present for at least 2 months
AND
• Symptomatic polyradiculoneuropathy as indicated by one of the following:
• Progressive or relapsing motor impairment of more than one limb
OR
• Progressive or relapsing sensory impairment of more than one limb
AND
• Electrophysiologic findings when three of the following four criteria are present:
• Partial conduction block of 1 or more motor nerve
• Reduced conduction velocity of 2 or more motor nerves
• Prolonged distal latency of 2 or more motor nerves
• Prolonged F-wave latencies of 2 or more motor nerves or the absence of F waves
AND
• Trial and failure, contraindication, or intolerance to one of the following standard of care treatments [3][4]:
• Corticosteroids (minimum 3 month trial duration)
• Immunoglobulin
• Plasma exchange
AND
• Prescribed by or in consultation with one of the following:
• Immunologist
• Neurologist
• Hematologist

Vyvgart Hytrulo

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Chronic inflammatory demyelinating polyneuropathy (CIDP)

• Patient demonstrates positive clinical response to therapy (e.g., Improvement in INCAT or aINCAT score)
AND
• Prescribed by or in consultation one of the following:
• Immunologist
• Neurologist
• Hematologist

P & T Revisions

2024-08-02, 2024-01-05, 2023-10-25, 2023-08-01, 2023-01-25, 2022-09-07, 2022-01-26

References

1. Vyvgart Prescribing Information. Argenx US, Inc. Boston, MA. April 2022.
2. Vyvgart Hytrulo Prescribing Information. Argenx US, Inc. Boston, MA. June 2024.
3. Koller H, Kieseier BC, Jander S, et al. Chronic inflammatory demyelinating polyneuropathy. N Engl J Med. 2005;352(13):1343-56.
4. Van den Bergh PYK, van Doorn PA, Hadden RDM et al. European Academy of Neurology/Peripheral Nerve Society guideline on diagnosis and treatment of chronic inflammatory demyelinating polyradiculoneuropathy: Report of a joint Task Force-Second revision. Eur J Neurol. 2021 Nov;28(11):3556-3583. doi: 10.1111/ene.14959. Epub 2021 Jul 30.

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Revision History

• 2024-08-02: Added criteria for Vyvgart Hytrulo for new CIDP indication
• 2024-01-05: 2024 UM Annual Review. No criteria changes. Background updates
• 2023-10-25: Removed t/f of Vyvgart IV and updated reauth language
• 2023-08-01: Addition of Vyvgart Hytrulo
• 2023-01-25: 2023 UM Annual Review. No changes to criteria. Updated references
• 2022-09-07: Added T/F/CI requirement for gMG. Changed initial authorization to 12 months. Updated background and references.
• 2022-01-26: New program for Vyvgart

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